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CDER MAPP on Clearing Articles, Speeches

[ Price : $8.95]

CDER issues a MAPP outlining policies for internal clearing of articles, speeches, and other communications written by Center empl...

Reps To Introduce Mobile Medical Apps Bill

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A bipartisan group of six House members say they will introduce legislation to limit FDA regulation of mobile medical apps to high...

Panel to Discuss Cochlear Implant System

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Federal Register Notice: FDAs Ear, Nose and Throat Devices Panel will meet 11/8 to discuss a Cochlear Americas PMA for the Nucleus...

Guidance on Heptatitis C Virus Drugs

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance: Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Dr...

ICH Elemental Impurities Guidance

[ Price : $8.95]

Federal Register Notice: FDA releases an ICH draft guidance: Elemental Impurities.

Public Citizen Challenges Change in Trial Subject Protection Guidance

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Public Citizen protests a HHS change in guidance on the remuneration of human clinical trial subjects.

Guidance on Acute Bacterial Skin and Skin Structure Infections

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance: Acute Bacterial Skin and Skin Structure Infections Developing Drugs for Treating...

Guidance on Veterinary AERs

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance, Data Elements for Submission of Veterinary Adverse Event Reports to the Center f...

CDER Reviewers Positive on Gileads Sofosbuvir

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CDER medical reviewers say Gilead's sofosbuvir appears to be acceptably safe and effective as a hepatitis C treatment in combinati...

ICH Guidance on Bacterial Endotoxins Test

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance, Q4B Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regi...